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Fibrin Glue in Inguinal Lymphadenectomy

Primary Purpose

Seroma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Application of fibrin glue sealant
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seroma focused on measuring Fibrin glue, Seroma, Inguinal lymphadenectomy, Wound complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Patients scheduled to perform ILND for various causes

Exclusion Criteria:

  • BMI more than 35,
  • Uncompensated diabetes
  • Advanced liver disease
  • Previous history of surgery and/or irradiation to the inguinal region
  • Preoperative chemotherapy
  • Significant coagulation disorders
  • Platelet counts <100,000/mL.
  • Use of systemic steroids or anticoagulants.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Fibrin glue

    Control

    Arm Description

    A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain.

    Lymphadenctomy wound was closed after insertion of a drain,

    Outcomes

    Primary Outcome Measures

    Number of Participants With Seroma Formation
    Collection of serous fluid under the wound flaps. According to the Common Terminology Criteria for Adverse Events (CTCAE) 4.0, Grade 2 and Grade 3 were considered. Grade 2 indicates it is symptomatic; simple aspiration indicated. Grade 3 indicates it is symptomatic, elective radiologic or operative intervention indicated

    Secondary Outcome Measures

    Full Information

    First Posted
    December 7, 2020
    Last Updated
    August 9, 2022
    Sponsor
    Menoufia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04666051
    Brief Title
    Fibrin Glue in Inguinal Lymphadenectomy
    Official Title
    Is There a Role for Fibrin Glue (Sealant) in Seroma Reduction After Inguinal Lymphadenectomy?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (Actual)
    Primary Completion Date
    October 2020 (Actual)
    Study Completion Date
    October 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Menoufia University

    4. Oversight

    5. Study Description

    Brief Summary
    Seroma is one of the most common encountered morbidities after inguinal lymph node dissection (ILND). It can cause not only much nuisance to both patients and doctors but also its presence can lead to many complications. This study aimed at evaluation of the role and effect of using fibrin glue on seroma reduction in patients undergoing ILND. Thirty-two patient have undergone ILND for various causes. The patients were randomized into two groups; 16 ILND in each. In one group, fibrin glue sealant was applied with a dose of 2ml per 100 cm2 surface area then drain placement was performed. Whereas, in the control group, only drain placement was used. Preoperative, operative and postoperative data were recorded and analyzed.
    Detailed Description
    Seroma is one of the most frequent complications occurring after ILND as it affects nearly one third of these cases. During the past decades, many actions have been tried in the perioperative care to decrease the incidence of these complications, as employing well vascularized bulky flaps to obliterate the dead space and to protect vessels, great saphenous vein sparing, strict bed rest and fibrin sealant application. Realizing the underlying pathology for seroma formation is the key point in its prevention. Thirty-nine patients scheduled to perform Inguinal lymphadenectomy for various causes have been checked for eligibility to be enrolled in this prospective, randomized study. Thirty-two patients have met the inclusion criteria. Inguinal lymphadenectomy has been performed including scarifying saphenous vein. Sartorius muscle transposition flap was routinely performed for protection of femoral vessels, then an 18 French conventional non-suction tube drain was inserted in all patients. All the previous steps were similar in both groups. At this stage, the wound was closed for the control group, while fibrin glue was prepared to be applied to the fibrin glue group in a dose of 2mL for 100 cm2 surface area. Postoperatively, the daily collected drain fluid was measured till the drain was removed when the daily drainage was less than 30 ml. Then the patients were planned to be followed up postoperatively for at least 4 weeks, to detect the possible clinically encountered complications as seroma, wound infection, or skin flap necrosis. Patients' demographic data and preexisting co-morbidities were recorded. Operative and pathological data regarding defect size, blood transfusion, primary tumor pathology, and number and status of retrieved lymph nodes were collected. The occurrence of post-operative seroma was the primary outcome. Other non serious adverse effect as hematoma, infection, or skin flap necrosis were recorded and compared between the two groups. The normality of distribution of variables was verified by Kolmogorov- Smirnov test. Chi-square test (Fisher or Monte Carlo) was used for comparisons between groups for categorical variables. Student t-test was used to compare two groups for normally distributed quantitative variables. For not normally distributed quantitative variables, Mann Whitney test was used to compare between two groups. P value was set to be significant if <0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Seroma
    Keywords
    Fibrin glue, Seroma, Inguinal lymphadenectomy, Wound complication

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fibrin glue
    Arm Type
    Experimental
    Arm Description
    A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Lymphadenctomy wound was closed after insertion of a drain,
    Intervention Type
    Biological
    Intervention Name(s)
    Application of fibrin glue sealant
    Primary Outcome Measure Information:
    Title
    Number of Participants With Seroma Formation
    Description
    Collection of serous fluid under the wound flaps. According to the Common Terminology Criteria for Adverse Events (CTCAE) 4.0, Grade 2 and Grade 3 were considered. Grade 2 indicates it is symptomatic; simple aspiration indicated. Grade 3 indicates it is symptomatic, elective radiologic or operative intervention indicated
    Time Frame
    4 weeks postpertively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • Patients scheduled to perform ILND for various causes Exclusion Criteria: BMI more than 35, Uncompensated diabetes Advanced liver disease Previous history of surgery and/or irradiation to the inguinal region Preoperative chemotherapy Significant coagulation disorders Platelet counts <100,000/mL. Use of systemic steroids or anticoagulants.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    M. Ashraf Balbaa, M.D.
    Organizational Affiliation
    Menoufia University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Study protocol will be available to be shared on request after study publication for 6 months.
    IPD Sharing Time Frame
    Six months from the time of study publication
    IPD Sharing Access Criteria
    Contacting the corresponding author
    Citations:
    PubMed Identifier
    22424660
    Citation
    Buda A, Fruscio R, Pirovano C, Signorelli M, Betti M, Milani R. The use of TachoSil for the prevention of postoperative complications after groin dissection in cases of gynecologic malignancy. Int J Gynaecol Obstet. 2012 Jun;117(3):217-9. doi: 10.1016/j.ijgo.2011.12.021. Epub 2012 Mar 15.
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    Fibrin Glue in Inguinal Lymphadenectomy

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